syngo.via View&GO is a software solution intended to be used for viewing, communication, and storage of medical images. It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options.

syngo.via View&GO supports interpretation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.

Device Description

Siemens Healthcare GmbH intends to market the Picture Archiving and Communications System, syngo.via View&GO, software version VA20A. This 510(k) submission describes several modifications to the previously cleared predicate device, syngo.via View&GO, software version VA10A.

syngo.via View&GO is a software only medical device, which is delivered by download to be installed on common IT hardware. This hardware has to fulfil the defined requirements. Any hardware platform that complies to the specified minimum hardware and software requirements and with successful installation verification and validation activities can be supported. The hardware itself is not seen as part of the medical device syngo.via View&GO and therefore not in the scope of this 510(k) submission.

syngo.via View&GO provides tools and features to cover the radiological tasks preparation for reading, reading images and support reporting. syngo.via View&GO supports DICOM formatted images and objects.

syngo.via View&GO is a standalone viewing and reading workplace. This is capable of rendering the data from the connected modalities for the post processing activities. syngo.via View&GO provides the user interface for interactive image viewing and processing with a limited short-term storage which can be interfaced with any Long-term storage (e.g. PACS) via DICOM syngo.via View&GO is based on Microsoft Windows operating systems.

syngo.via View&GO supports various monitor setups and can be adapted to a range of image types by connecting different monitor types.

The subject device and the predicate device share the same fundamental scientific technology. This device description holds true for the subject device, syngo.via View&GO, software version VA20A, as well as the predicate device, syngo.via View&GO, software version VA10A.

AI/ML Overview

The provided text is a 510(k) summary for the medical device syngo.via View&GO (Version VA20A). It compares this device to a predicate device (syngo.via View&GO, Version VA10A) and outlines the testing performed to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a quantitative manner. Instead, it describes "performance tests" that were conducted to test the "functionality of the device." The summary states:

Acceptance Criteria (Implicit from the document's claims):

Continued conformance with special controls for medical devices containing software.
All software specifications have met the acceptance criteria.
Acceptable verification and validation for the device to support claims of substantial equivalence.
The device performs comparably to and is as safe and effective as the predicate device.
The device does not introduce any new significant potential safety risks.

Reported Device Performance:
The document states that the "results of all conducted testing were found acceptable in supporting the claim of substantial equivalence." This implies that the device met all implicit acceptance criteria by successfully passing the functionality tests.

The document highlights the following general performance findings:

The subject device (VA20A) and the predicate device (VA10A) share the same fundamental scientific technology.
The changes between the predicate and subject device (e.g., added reprocessing algorithms, anatomical range presets, DICOM printer support) do not impact the safety and effectiveness of the subject device.
The software documentation is in conformance with FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Risk analysis was completed, and risk control was implemented to mitigate identified hazards.
Cybersecurity requirements were met by implementing processes for preventing unauthorized access, modifications, misuse, or denial of use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data). It broadly mentions "non-clinical tests were conducted for the device syngo.via View&GO during product development" and "testing for verification and validation for the device was found acceptable." This suggests internal testing by the manufacturer rather than a study with a specific patient dataset described for a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The testing described is verification and validation of software functionality, not a clinical study involving human interpretation of images and ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. As mentioned above, the testing appears to be centered on software functionality verification and validation, not a clinical study requiring adjudication of expert readings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader, multi-case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) summary. The device is a "Picture Archiving and Communications System" and a "software solution intended to be used for viewing, manipulation, communication, and storage of medical images." It is not described as an AI-powered diagnostic aid meant to directly improve human reader performance in the context of an MRMC study. The document explicitly states: "No automated diagnostic interpretation capabilities like CAD are included. All image data are to be interpreted by trained personnel."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study focused on algorithmic diagnostic accuracy was not done or at least not described in this 510(k) summary for diagnostic purposes. The device is a viewing and processing software, not an algorithm providing diagnostic interpretations. The testing focused on technical functionality, safety, and equivalence to a predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Since this submission pertains to a picture archiving and communication system (PACS) for viewing and manipulation, not a diagnostic AI algorithm, the concept of "ground truth" as typically used in diagnostic performance studies (e.g., pathology, clinical outcomes) for the entire device as a whole is not applicable or described. The "ground truth" for the verification and validation would likely be based on technical specifications, expected software behavior, and known standards (e.g., DICOM compliance).

8. The sample size for the training set

This information is not provided and is not applicable as the device is not described as an AI model developed through machine learning with a distinct training set. It's a software solution with defined functionalities.

9. How the ground truth for the training set was established

This information is not provided and is not applicable as the device is not an AI model that undergoes a training phase requiring a "training set" with established "ground truth" in the traditional sense of machine learning for diagnostic tasks.

Summary

{0}------------------------------------------------

July 1, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Siemens Healthcare GmbH % Mr. Elango Rangappan Regulatory Affairs Manager Siemensstr. 1 Forchheim, 91301 GERMANY

Re: K201477

Trade/Device Name: syngo.via View&GO (Version VA20A) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: May 27, 2020 Received: June 3, 2020

Dear Mr. Rangappan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting

{1}------------------------------------------------

combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K201477

Device Name syngo.via View&GO (Version VA20A)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K201477

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Date prepared: May 27, 2020

1. Submitter: Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany
  Establishment Registration Number: 3004977335

2. Contact Person:

Mr. Elango Alampalayam Rangappan Regulatory Affairs Manager Siemens Healthcare GmbH, Siemensstr. 1 91301 Forchheim Germany E-mail: ar.elango@siemens-healthineers.com Telephone: +49 (9191) 18-4429 Fax: +49 (9191) 18-4404

3. Device Name and Classification:

Trade Name:	syngo.via View&GO (Version VA20A)
Classification Name:	Picture Archiving and Communications System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.2050
Device Class:	Class II
Product Code:	LLZ

4. Legally Marketed Predicate Device:

Trade Name:	syngo.via View&GO (Version VA10A)
510(k) Clearance:	K182208
Clearance Date:	Sept 7, 2018
Classification Name:	Picture Archiving and Communications System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.2050
Device Class:	Class II
Product Code:	LLZ
Recall Information:	This predicate device has not been the subject of anydesign related recalls.

{4}------------------------------------------------

5. Device Description:

syngo.via View&GO supports various monitor setups and can be adapted to a range of image types by connecting different monitor types.

6. Intended Use:

syngo.via View&GO is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options.

syngo.via View&GO supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.

The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.

{5}------------------------------------------------

2020
GmbH.
Healthcare
© Siemens

N

Summary of Differences between the Subject Device and the Predicate Device:
The following table compares the functionality of syngo. via View&O V A20A to the predicate dev

Device name and version (K number)	Manufacturer	Subject device syngo.via View&GO (Version VA20A)	Predicate device syngo.via View&GO VA10A (K182202)	Comparison	Impact to Safety & Effectiveness
Intended use		syngo.via View&GO is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.	syngo.via View&GO is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.	Same	NA
		It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options.	It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options.
		syngo.via View&GO supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.	syngo.via View&GO supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
		The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.	The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.
Software architecture		Standalone workplace system that is logically broken down to syngo.via View&GO subsystems. Subsystems are further broken down to syngo modules	Standalone workplace system that is logically broken down to syngo.via View&GO subsystems. Subsystems are further broken down to syngo modules.	Same	NA
	Siemens Healthcare GmbH	Siemens Healthcare GmbH		New product version	NA
	Subject device	Predicate device	Comparison	Impact to Safety & Effectiveness
Image communication	Standard network protocols like TCP/IP and standard communication protocol DICOM.	Standard network protocols like TCP/IP and standard communication protocol DICOM.	Same	NA
Imaging algorithms	Multiplanar reconstruction (MPR)Maximum and Minimum Intensity Projection (MIP/MinIP)Volume Rendering Technique (VRT) with additional edge and surface enhancements and control over rendering parametersShaded Surface Display (SSD)Digitally Reconstructed RadiographEditor functionality (e.g. Clip-Box)RegistrationAnatomical registrationRegion growingAutomatic Spine Labeling, also for ribs in CT thorax scans19 ("Rib labeling")Reprocessing X-ray projection images into 3D image and Topograms17	Multiplanar reconstruction (MPR)Maximum and Minimum Intensity Projection (MIP/MinIP)Volume Rendering Technique (VRT) with additional edge and surface enhancements and control over rendering parametersShaded Surface Display (SSD)Digitally Reconstructed RadiographEditor functionality (e.g. Clip-Box)RegistrationAnatomical registrationRegion growingAutomatic Spine Labeling, also for ribs in CT thorax scans20 ("Rib labeling")	The reprocessing algorithms was been added to the existing algorithms in the subject device when compared to the predicate device	The changes between the predicate device and the subject device doesn't impact the safety and effectiveness of the subject device as the necessary measures taken for the safety and effectiveness of the subject device
Quantitative algorithms	Distance, angle, VOI and ROI measurements	Distance, angle, VOI and ROI measurements	Same	NA

{6}------------------------------------------------

emens Healthcare GmbH,

Pick Labeling as a functionality a 10(k) clearane with device SWGC, CT BONE READING, KI 23584.
P Rib Labeling as a functionality a 510(k) clerance with device SINCO, CT DONE

"Reprocessing algorithm as a functionality was already covered by the 510(k) clearance with device syngo X-Workplace SW VD10,

{7}------------------------------------------------

	Subject device	Predicate device	Comparison	Impact to Safety & Effectiveness
Supported Image Generating Modalities	The following Image types are supported by syngo.via View&GO:- CT Image (Computed Tomography)- MR Image (Magnetic Resonance)- NM Image (Nuclear Medicine)- XA Image (X-Ray Angiography)- US Image (Ultrasound)- DX Image (Digital Radiography)- DICOM secondary capture objects	The following Image types are supported by syngo.via View&GO:- CT Image (Computed Tomography)- MR Image (Magnetic Resonance)- NM Image (Nuclear Medicine)- XA Image (X-Ray Angiography)- US Image (Ultrasound)- DX Image (Digital Radiography)- DICOM secondary capture objects	Same	NA
Image data Compression	Receive & Store:Images are received and stored as received without any change in the compression format.Display:Images are displayed as received without any change in the compression.Lossy compression images are displayed with an indication to the user with the compression ratio.Export:To DICOM Node: Images are sent as per the DICOM negotiation. Uncompressed is preferred and lossy compression is not supported.To Exchangeable media: Images exported as stored in the local storage.	Receive & Store:Images are received and stored as received without any change in the compression format.Display:Images are displayed as received without any change in the compression.Lossy compression images are displayed with an indication to the user with the compression ratio.Export:To DICOM Node: Images are sent as per the DICOM negotiation. Uncompressed is preferred and lossy compression is not supported.To Exchangeable media: Images exported as stored in the local storage	Same	NA
	Subject device	Predicate device	Comparison	Impact to Safety & Effectiveness
System	Supported Compressions for export:lossless compression algorithms,JPEG, JPEG 2000 and RLE.Workplace:Microsoft Windows 10 – 64 bit or higherMicrosoft Windows 7 – 64 bit SP1(for update only)	Supported Compressions for export:lossless compression algorithms,JPEG, JPEG 2000 and RLE.Workplace:Microsoft Windows 7 – 64 bit SP1Microsoft Windows 10 – 64 bit	Same.Note: In the subject device the Windows 7Operating System supported only for updates.	NA
Image Generation	None.syngo.via View&GO is a pure post processing software and there is no influence on the image generating devices	None.syngo.via View&GO is a pure post processing software and there is no influence on the image generating devices	NA as both the devices do not impact the Image generating devices.	NA
CAD Functionalities	None.No automated diagnostic interpretation capabilities like CAD are included. All image data are to be interpreted by trained personnel.	None.No automated diagnostic interpretation capabilities like CAD are included. All image data are to be interpreted by trained personnel.	NA as both the devices don't support any CAD functionalities.	NA
Software self-test / checks	Intimate the user in case the data transfer is interrupted to the connected DICOM node.Hardware / Operating system compatibility check during Installation.Display Compatibility Check supports the end user to qualify the system for proper diagnostic use.	Intimate the user in case the data transfer is interrupted to the connected DICOM node.Hardware / Operating system compatibility check during Installation.Display Compatibility Check supports the end user to qualify the system for proper diagnostic use.	Same	NA
	Subject device	Predicate device	Comparison	Impact to Safety & Effectiveness
Cyber Security	User access controlAudit trailsDocumentation of system securityinformation, Network traffic &Firewall controlSupport of virus / malware protec-tion.	User access controlAudit trailsDocumentation of system securityinformation, Network traffic &Firewall controlSupport of virus / malware protec-tion.	Same	NA
Hardware	Hardware is not understood as part ofthe medical device but needs to complywith the minimum requirements asspecified by syngo.via View&GO.	Hardware is not understood as part ofthe medical device but needs to com-ply with the minimum requirements asspecified by syngo.via View&GO.	Same	NA
Software functionalities
Graphical User Interface		Yes, with reduced color palette,clearer structure and text labels onicons.	Yes, with reduced color palette,clearer structure and text labels onicons	Same	NA
Patient Browser		Yes, with simplified search function-ality, clearer structure of search re-sults, image preview, unlimitedsearch results, periodic updates ofsearch results.	Yes, with simplified search function-ality, clearer structure of search re-sults, image preview, unlimited searchresults, periodic updates of search re-sults.	Same.	NA
Series navigator		The Series Navigator lists all cur-rently loaded data within a workflow.	Yes, the Series Navigator lists all cur-rently loaded data within a workflow.	Same	NA
Findings / Reporting		No, reporting support is provided tocreate reports using any 3rd party re-porting tool. Hence the findings alsocannot be navigated.	No, reporting support is provided tocreate reports using any 3rd party re-porting tool. Hence the findings alsocannot be navigated.	Same	NA
	Subject device	Predicate device	Comparison	Impact to Safety & Effectiveness
Import and export of data	Import of DICOM data from networknodes or external media, and of DI-COM-compliant or non DICOM-compliant data from external mediaand Windows file system.Export to USB, Windows file sys-tem, or other DICOM nodes.	Import of DICOM data from networknodes or external media, and of DI-COM-compliant or non DICOM-compliant data from external mediaand Windows file system.Export to USB, Windows file system,or other DICOM nodes.	Same	NA
Archiving data	Data can be sent to an archive ifsyngo.via View&GO is connected toa PACS or corresponding DICOMnode.	Data can be sent to an archive ifsyngo.via View&GO is connected toa PACS or corresponding DICOMnode.	Same	NA
Ranges	Yes, parallel, radial, Radial sliced,Curved and Spine ranges are sup-ported. Additionally, AnatomicalRange presets21 can be created.	Yes, parallel, radial, Radial sliced,Curved and Spine ranges are sup-ported. But Range presets are notsupported.	In the subject device,additionally the Ana-tomical range presetsare supported. Presetscontain predefined an-atomic values to indi-cate which related ana-tomical structure andbody region is dis-played and to help po-sition the range as re-quired.	This difference between thepredicate device and thesubject device doesn't im-pact the safety and effec-tiveness of the subject de-vice as the necessarymeasures taken for thesafety and effectiveness ofthe subject device.
Spine/Rib labeling	Yes, with suggested spine labels tobe confirmed by the user, and addi-tional smart placement of labels, alsoin inter-vertebra regions, support of	Yes, with suggested spine labels tobe confirmed by the user, and addi-tional smart placement of labels, alsoin inter-vertebra regions, support of	Same	NA
	Subject device	Predicate device	Comparison	Impact to Safety & Effectiveness
	2D images, support of multi-seriesstudies, and added support for rib labels.	2D images, support of multi-seriesstudies, and added support for rib labels.	Same	NA
Communication	Yes, Interface with DICOM is sup-ported.	Yes, Interface with DICOM is sup-ported.	Same	NA
Printing	Yes, both paper and DICOM printingsupported.	Yes, only paper printing supported.	In the subject deviceprint support added forDICOM printers in ad-dition to the paperprinters as in predicatedevice.	This difference between thepredicate device and thesubject device doesn't im-pact the safety and effec-tiveness of the subject de-vice as the necessarymeasures taken for thesafety and effectiveness ofthe subject device.
Online help system	Yes, with reduced color palette,clearer structure and text labels onicons.	Yes, with reduced color palette,clearer structure and text labels onicons.	Same	NA
Markers and annotations	Yes,with support for marking a posi-tion on an image and textual an-notations.	Yes,with support for marking a posi-tion on an image and textual an-notations.	Same	NA

510(k) for syngo.via View&GOVA20A

{8}------------------------------------------------

{9}------------------------------------------------

510(k) for syngo.via View&GOVA20A

{10}------------------------------------------------

Siemens Healthcare GmbH, 201

21 Range Presets as a functionality was already covered by a 510(k) clearance with device syngo.via (version VB40A), K191040

{11}------------------------------------------------

Table 13: Substantial equivalency informatio

{12}------------------------------------------------

8. Non-clinical Performance Testing:

Non-clinical tests were conducted for the device syngo.via View&GO during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.

Siemens Healthcare GmbH claims conformance to the following standards:

NEMA PS 3.1 3.20 (2016) Digital Imaging and Communications in Medicine (DI--COM) Set
ISO/IEC 10918-1 First edition 1994-02-15 + Technical Corrigendum 1 (2005) (JPEG) -
ISO/IEC 15444-1:2016 (JPEG2000) -
ISO 14971 Second edition 2007-03-01 -
IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION -
IEC 82304-1 Edition 1.0 2016-10 -
-IEC 62366-1 Edition 1.0 2015-02
IEEE Std 3333.2.1-2015 -

Software Verification and Validation:

Software documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the device syngo.via View&GO during product development.

The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.

Siemens Healthcare GmbH conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Contained in Section B of this submission are our cybersecurity considerations as they relate to the device syngo.via View&GO.

Summary:

Performance tests were conducted to test the functionality of the device syngo.via View&GO. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.

{13}------------------------------------------------

9. Safety and Effectiveness Information:

Software specifications, design descriptions, hazard analysis, and labeling information are submitted in support of this premarket notification. The device labeling contains instructions for use with cautions to provide for safe and effective use of the device.

The results of the hazard analysis combined with the appropriate preventive measures taken indicate the device is of moderate level of concern, as per the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).

10. Conclusion as to Substantial Equivalence:

The predicate device was cleared based on non-clinical supportive information. The comparison of technological characteristics, device hazards, non-clinical performance data, and software validation data demonstrates that the subject device performs comparably to and is as safe and effective as the predicate device that is currently marketed for the same intended use.

In summary, we are of the opinion that the subject device syngo.via View&GO, software version VA20A, does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate device.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).